Momentis Surgical Secures FDA Clearance for Advanced Anovo® Robotic Platform, Setting New Standards in Single-Incision Surgery

Momentis Surgical Ltd., a leader in robotic-assisted surgical innovation, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its second-generation Anovo^® robotic surgical platform. The system’s first approval was an FDA De Novo marketing authorization for the use of Anovo in single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures including benign hysterectomy. It is the first and only FDA-authorized surgical robotic platform that features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation.

The second generation Anovo platform, built on years of clinical insights, brings a suite of upgrades to enhance surgeon experience and ease of use, including the first FDA-cleared robotic system (single-port or multi-port) capable of operating in both retroflexion and anteflexion. The Anovo platform delivers unprecedented reach and articulation from a single incision. Surgeons can now also experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures. Furthermore, a new annotation-enabled video overlay enhances in-room communication and supports teaching and collaboration among medical teams.

Ricardo E. Estape, MD, a practicing gynecology oncologist at Kendall Regional Medical Center and director of HCA Healthcare's Institute for Gynecologic Oncology and long-time user of the Anovo system, praised the updated platform: “The additional features of the second-generation system really unlock the capabilities of the robot. The new controllers, haptic feedback and the floor mounted pedestal make the system extremely easy to use.”

Dvir Cohen, CEO of Momentis Surgical, stated: “This second-generation platform, combined with our expanded surgical indications, underscores our commitment to the long-term plan of transforming the field of robotic surgery with our versatile surgical platform. This new FDA clearance is another milestone in the execution of our long term plan to take robot-assisted surgeries to the next level.”

Cohen added: “We are building strong momentum following the impressive clinical outcomes we’ve achieved in gynecology. Our focus now is on expanding Anovo’s applications to additional indications, including general surgery. Alongside these advancements, we aim to broaden our global presence and look forward to introducing Anovo to markets in Europe and Asia in the future.”

Momentis Surgical is backed by leading life sciences investors, including Peregrine Ventures, Ceros, OurCrowd and Accelmed.

“The small size and ease of use of the Anovo platform make it ideal for more surgeons to offer patients robotic surgery solutions at sites of care beyond the hospital setting, like outpatient Ambulatory Surgery Centers,” said Michael Conditt, PhD, SVP of Strategic Marketing and Clinical Development at Momentis Surgical. “The new features of our second-generation system will enable us to pursue further indication expansions into bariatric, colorectal and ENT surgeries."